Influence on the Effect of an Oral Contraceptive Drug After Administration of Liraglutide in Postmenopausal Women

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: liraglutide; Drug: placebo; Drug: levonorgestrel / ethinylestradiol

• Registration Number: NCT01508858
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a combination contraceptive drug (Neovletta®).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• Postmenopausal woman
• Body Mass Index (BMI) between 18.0-30.0 kg/m^2 (both inclusive)
• Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, blood and urinary laboratory assessments

Exclusion Criteria

• History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator
• Impaired renal function
• Active hepatitis B and/or active hepatitis C
• Positive HIV (human immunodeficiency virus) antibodies
• Known or suspected allergy to trial products or related products
• Pregnant or positive pregnancy test at screening or nursing mother
• Use of prescription or non-prescription medication within 2 weeks prior to first dosing with trial products which in the Investigators opinion will interfere with the pharmacokinetics of the compounds in Neovletta®
• Use of hormone replacement therapy within 4 weeks prior to starting dosing with trial product
• History of alcoholism or drug abuse
• Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
• Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
• Excessive consumption of a diet deviating from a normal diet as judged by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment period 1	placebo	-
Treatment period 2	levonorgestrel / ethinylestradiol	-
Treatment period 1	levonorgestrel / ethinylestradiol	-
Treatment period 2	placebo	-
Treatment period 1	liraglutide	-
Treatment period 2	liraglutide	-

Primary Outcome Measures

Name	Time	Method
AUC of ethinylestradiol
AUC of levonorgestrel

Secondary Outcome Measures

Name	Time	Method
Cmax, maximum concentration
tmax, time to reach Cmax
Adverse events
t½, terminal half-life
AUC (0-t)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Uppsala, Sweden